Monidor Reaches Major Milestone as Monidor Vitals Gains MDR Class IIb CE Approval for Home Healthcare Use
20.1.2026
Monidor Vitals has received its updated MDR Class IIb CE certification, extending its approved use from in-hospital environments to home healthcare. The certification marks a significant milestone for the company, as Class IIb approval for home use remains rare within the medical device industry.
With this update, Monidor Vitals is now certified for hospital-grade remote monitoring both in clinical settings and in hospital-at-home models. In addition, the updated version introduces significantly more flexible alarm configuration based on user feedback. User units can now, for example, define ward-specific default alarm limits and alarm delays, as well as select which devices receive alarms, improving usability and workflow efficiency in different care settings.
The platform delivers wireless pulse oximetry, including continuous monitoring of SpO₂, pulse, and photoplethysmography (PPG). The solution supports use cases such as pulmonary monitoring in hospitals and hospital-at-home settings.
“The Monidor Vitals platform is now solid, scalable, and ready for growth,” says Mikko Savola, CEO of Monidor Oy. “Pulse oximetry represents the first step in Monidor’s long-term platform strategy. Building on this foundation, Monidor Vitals will evolve into a multi-parameter wireless monitoring platform through the integration of additional high-quality sensors in collaboration with selected partners.”
Monidor Vitals is a CE-marked medical device under the EU Medical Device Regulation (MDR).
For more information, please contact:
Mikko Savola
CEO, Monidor Oy